Limus Eluted From A Durable Versus ERodable Stent Coating

Not Applicable

Completed

• Conditions: Coronary Stenosis; Coronary Disease

• Registration Number: NCT00389220
• Lead Sponsor: Biosensors Europe SA

Brief Summary

The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

Detailed Description

Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Study Timeline

• Study First Submitted: 2006-10-13
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-18
• Study Start: 2006-11
• Primary Completion: 2008-05
• Study Completion: 2012-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1707

Inclusion Criteria

• Age >= 18 years;
• Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
• Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
• No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria

• Pregnancy;
• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
• Inability to provide informed consent;
• Currently participating in another trial before reaching first endpoint;
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.	9 month	Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) in the overall population according to the ARC definitions.	5 year	Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
Cardiac death	5 year	Cardiac death
In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA.	9 month	In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
All deaths	5 years	All deaths (cardiac and non-cardiac)
In-stent and in-segment binary restenosis rate as assessed by QCA.	9 month	In-stent and in-segment binary restenosis rate as assessed by QCA.
In-stent and in-segment late luminal loss	9 month	In-stent and in-segment late luminal loss as assessed by QCA
Myocardial infarction	5 years	Myocardial infarction (Q-wave and NQWMI)
In-segment percent diameter stenosis (%DS).	9 month	In-segment percent diameter stenosis (%DS) as assessed by QCA
Device success, lesion success and procedural success.	at implant
Angiographic and clinical stent thrombosis.	5 years	Angiographic and clinical stent thrombosis

Trial Locations

Locations (10)

Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164; 🇧🇪 Aalst, Belgium

L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert; 🇫🇷 Massy, France

Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39; 🇩🇪 Leipzig, Germany

Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1; 🇩🇪 Munich, Germany

Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77; 🇩🇪 Munich, Germany

University Medical Center Rotterdam Erasmus, Thoraxcentrum; 🇳🇱 Rotterdam, Netherlands

American Heart of Poland Sp. z o.o.; 🇵🇱 Dąbrowa Górnicza, Poland

Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital; 🇨🇭 Bern, Switzerland

University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100; 🇨🇭 Zurich, Switzerland

Royal Brompton Hospital, Sydney Street; 🇬🇧 London, United Kingdom